Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Genetic Study of Children With Soft Tissue Sarcoma or Rhabdomyosarcoma
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Genetics | Closed | Children | NCI | COG-AB9804 CCG-B9804, NCT00003793, AB9804 |
Objectives
- Identify genetically susceptible patients to therapy-induced myelodysplastic syndrome or acute myelogenous leukemia (t-MDS/AML) prior to initiation of high-dose chemotherapy for sarcoma.
- Identify patients who are at increased risk of t-MDS/AML during or after therapy.
Entry Criteria
Disease Characteristics:
- Diagnosis of sarcoma including:
- Rhabdomyosarcoma
- Ewing's sarcoma
- Primitive neuroectodermal tumor
- Fibrosarcoma
- Malignant peripheral nerve sheath tumor
- Synovial cell sarcoma
- Osteosarcoma
- Other soft tissue sarcoma
- Must be currently receiving intensive or high-dose chemotherapy for sarcoma
Prior/Concurrent Therapy:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Patient Characteristics:
Age:
- Children
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Expected Enrollment
321A total of 321 patients will be accrued for this study within 4 years.
Outline
Blood is collected from patients at diagnosis (preferably before chemotherapy or transfusion), at end of therapy, and at 6 months, 1 year, 2 years, and 3 years after therapy.
Blood specimens are examined by clonality analysis (HUMARA), variant cell frequency (glycophorin A assay), GST NAT2/CYP1A1 genotyping, microsatellite instability, and ras mutation detection (single strand conformation polymorphism and sequencing of mutant alleles).
Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.
Trial Lead Organizations
Children's Oncology Group
 | | | |
| Stella Davies, MBBS, PhD, Protocol chair | |
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| Registry Information | ||
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| Official Title | Clinical and Biological Predictors of Therapy-Related Leukemia | |
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| Trial Start Date | 1998-12-18 | |
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| Registered in ClinicalTrials.gov | NCT00003793 | |
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| Date Submitted to PDQ | 1998-12-16 | |
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| Information Last Verified | 2010-11-18 | |
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| NCI Grant/Contract Number | CA98543 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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